Field
The present invention is directed to compositions and methods for diagnosing thyroid cancer and evaluating thyroid nodules to determine if they are benign or cancerous.
Description of the Related Art
Approximately 350,000 fine needle aspirate (FNA) biopsies of thyroid nodules are performed every year in the US, of which 20% are reported as indeterminate with respect to whether the nodules are cancerous or not. These patients, in most cases, undergo surgery given the risk of cancer, which ranges between only 15 to 30%. This means that most patients do not require surgical removal of the thyroid. Considering the acute and long term risks associated to thyroid surgery, as well as the costs for patients and the health system, there is an urgent need for a tool that will improve the diagnostic accuracy of thyroid FNA biopsies.
Recently, new tests have been placed in the US market that, to a variable degree, improve the diagnosis of indeterminate thyroid nodules. These include the Afirma® thyroid FNA analysis test (Veracyte, South San Francisco, Calif.), which is a gene expression classifier assay based on 167 genes. However, the Afirma® test would change the surgical conduct correctly in only about 50% of the cases. Two other test include those developed by Quest Diagnostics and Asuragen, which are based on mutational analysis of known biomarkers accepted by the American Thyroid Association. However, adequate clinical trial validation is lacking Unfortunately, the Afirma® test demands the analysis of a large number of biomarkers, all tests must be performed in central laboratories, and require the sample be shipped for analysis. In addition, a second FNA must be performed to obtain an adequate sample to perform these assays.
Clearly, there is a need in the art for improved methods and compositions for evaluating thyroid nodules and diagnosing thyroid cancer. The present invention meets this need by providing a new and simplified diagnostic approach for evaluating thyroid nodules that have been reported to be indeterminate by a fine needle aspiration (FNA) biopsy, and provides additional advantages.